Phase 2
Completed N=90
A Study of Avastin (Bevacizumab) in Combination With Xelox and Tarceva in Patients With Metastatic Colorectal Cancer.
Source: ClinicalTrials.gov NCT01135498 ↗Enrolled (actual)
90
Serious AEs
36.7%
Results posted
Feb 2015
Primary outcomePrimary: Percentage of Participants With Disease Progression or Death — 61.1 percentage of participants
Summary
This study will evaluate the efficacy and safety of a first-line regimen of Avastin and Xelox (Xeloda + Eloxatin) followed by Avastin and Tarceva, in patients with metastatic colorectal cancer. Patients will receive 6 x 21 day cycles of treatment with Avastin (7.5mg/kg iv on day 1), Xeloda (1000mg/m2 po twice daily on days 1 to 14) and Eloxatin (130mg/m2 iv on day 1). Patients free of disease progression will then continue with Avastin (7.5mg/kg iv once every 3 weeks) and Tarceva (150mg po daily). The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Disease Progression or Death |
61.1 | — |
| PRIMARY Progression-Free Survival |
9.18 | — |
| SECONDARY Percentage of Participants Achieving Objective Response (Complete Response [CR] or Partial Response [PR]) |
55.95 | — |
| SECONDARY Percentage of Participants Achieving Disease Control (CR, PR, or No Change [NC]) |
92.86 | — |
| SECONDARY Percentage of Participants Who Died |
58.89 | — |
| SECONDARY Overall Survival (OS) |
25.79 | — |
Eligibility Criteria
Inclusion Criteria
- adult patients, >=18 years of age;
- adenocarcinoma of colon or rectum, with metastatic disease;
- >=1 measurable lesion.
Exclusion Criteria
- previous treatment with Avastin or Tarceva;
- previous systemic treatment for advanced or metastatic disease;
- adjuvant treatment for non-metastatic disease in past 6 months.
Data sourced from ClinicalTrials.gov (NCT01135498). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.